Sterile X-ray Detectable Lap Sponges

Requirement of lap sponge auxiliary materialraw material:

1) Content of barium sulphate of X ray tape or x ray thread of Sterile x-ray detectable lap sponges shall be ≧ 60% and the material shall be opaque. 

2) The weight of mono-filament x ray thread shall be ≧ 0.5g/m; The weight of multifilament x ray thread shall be ≧ 0.28g/m.

3) The stitching thread of lap sponge shall be 100% cotton thread without fluorescence.

4) Blue loop shall has high color fastness.

5) Both blue loop and white loop of lap sponge shall be fluorescence free.

Size and tolerance of lap sponges (part of normal sizes):

Lap sponge quality standards:

1)Lap sponge shall be clean without bad smell. There shall be no such defects as mildewed spots, impurities, stains and holes.

2)Before being stitched , gauze shall be folded flat and tidy. Every gauze edge shall  be sewn inside and so no broken thread shall be left outside.

3)The stitching shall be flat, tidy, firm and even. There shall be 6 to 7 stitches every inch. Back stitching shall be made at the beginning , end and when there is a broken thread.

4)X ray thread or x ray tape ( chip) shall be bright and clean with even diameter or thickness. There shall be no stains, impurities or bad smell.

5)No broken threads shall be left on lap sponge.

6)The total of bacteria colony of non sterile lap sponge shall be ≦100 cfu/g. Pathogenic bacteria shall not be detected.

7)If EO gas is adopted to sterilize lap sponge, the residue of EO gas shall not be more than 10mg/kg.

FACTORY CERTIFICATION:

Our factory has established and applies a quality assurance system, which is subject to periodic surveillance, defined by Annex V, section 4 of the aforementioned directive.

ENIS0 13485:2012

ENIS0 13485:2012/AC:2012 are fulfilled.

The requirements of Annex V of the directive 93/42/EEC have been met for the surgical gauze products including gauze swab and lap sponge,etc.